BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 21114216 · Received January 9, 2025

    Report

    Report Number
    2029046-2025-00091
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    December 12, 2024
    Report Date
    January 9, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009774
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31412312L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION AND THE PATIENT EXPERIENCED ARTERY DISSECTION THAT REQUIRED INTERVENTIONAL RADIOLOGY INTERVENTION AND ADMISSION. DURING THE CASE, IT WAS SUSPECTED THAT AN AORTIC DISSECTION OCCURRED IN THE PATIENT. WHEN THE PHYSICIAN WAS ADVANCING THE THERMOCOOL SMARTTOUCH SF CATHETER INTO THE GROIN, AND UP THROUGH THE ARTERY, IN ORDER TO ACCESS THE VENTRICLE FOR THE VENTRICULAR TACHYCARDIA (VT) ABLATION, THE PHYSICIAN HAD ENCOUNTERED SOME RESISTANCE DOWN LOWER IN THE ARTERY WITH THE THERMOCOOL SMARTTOUCH SF CATHETER. CONTRAST DYE WAS ADMINISTERED TO THE PATIENT. INTERVENTIONAL RADIOLOGY WAS CALLED TO TREAT THE PATIENT, AND THE PATIENT WAS ADMITTED TO INTERVENTIONAL RADIOLOGY (IR). INTERVENTIONAL DOCTOR CAME INTO THE PROCEDURE TO EVALUATE AND REQUESTED THAT THE PATIENT BE MOVED TO AN IR LAB WITH MORE APPROPRIATE EQUIPMENT. IT WAS SAID BY THE LAB STAFF THAT THE INJURY COULD HAVE POSSIBLY BEEN A MESENTERIC ARTERY DISSECTION; HOWEVER, THE REPORTER WAS UNABLE TO CONFIRM THIS. NO ABLATION HAD BEEN PERFORMED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379457 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31412312L 10846835009774

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H| L NGEN PUMP, US CONFIGURATION.| NGEN RF GENERATOR, US.